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Abstract:

Spinal implants and methods for spinal stabilization and/or fusion are
provided. Exemplary implants described herein can be configured for
delivery to a facet joint to stabilize and/or fuse the facet joint, and
can optionally be anchored within the pedicle for added fixation. The
implant can optionally include a fusion-promoting bioactive material
thereby providing a single device capable of spinal stabilization and/or
fusion. Furthermore, a method of placing such an implant within a facet
joint is provided.

Claims:

1. A spinal implant, comprising: an elongate member having a proximal
head with a shank extending distally therefrom, the shank having a thread
extending over at least a portion thereof, the proximal head being
substantially spherical with an annular rim extending proximally
therefrom; and a stabilization member configured to rotate in all
directions relative to the proximal head of the elongate member, the
stabilization member having a proximal portion with an expandable
diameter that is configured to seat the proximal head of the elongate
member, wherein the annular rim is configured to limit rotation of the
stabilization member to prevent the stabilization member from extending
over a proximal surface of the proximal head.

2. The spinal implant of claim 1, wherein the stabilization member
includes a distal portion having at least one feature configured to
engage a bony portion of a facet joint.

3. The spinal implant of claim 2, wherein the distal portion includes a
plurality of bone piercing tines configured to engage a bony portion of a
facet joint.

4. The spinal implant of claim 1, wherein the elongate member is
cannulated.

5. The spinal implant of claim 3, wherein an outer surface of the
plurality of bone piercing tines are angled inward toward the shank.

6. The spinal implant of claim 1, wherein the proximal head includes an
expandable opening formed in a proximal portion thereof and
concentrically aligned with the annular rim, the expandable opening
configured to receive a set screw.

7. The spinal implant of claim 6, wherein the proximal head and the
annular rim include at least one slit formed in a sidewall thereof
configured to allow the proximal head to expand to receive a set screw.

8. The spinal implant of claim 7, wherein the proximal head and the
annular rim are configured to expand to engage and interlock with the
stabilization member when a set screw is disposed within the expandable
opening.

9. The spinal implant of claim 6, wherein the proximal head includes a
driving feature disposed distally to the expandable opening and
configured to receive a driving tool to facilitate insertion of the
elongate member.

10. The spinal implant of claim 1, wherein the proximal portion comprises
a plurality of arms configured to expand to engage the proximal head.

11. The spinal implant of claim 1, wherein at least a portion of the
shank is unthreaded.

12. The spinal implant of claim 1, wherein the implant includes a
fusion-promoting bioactive material.

13. A spinal implant, comprising: a distal bone engaging shank having a
thread extending over at least a portion thereof; a head formed on a
proximal end of the shank and coupled to a stabilization member, the head
being configured for rotational movement in all directions relative to
the stabilization member; and a rotation stop formed on a proximal
portion of the head and configured to engage a proximal portion of the
stabilization member to limit rotational motion of the head relative to
the stabilization member.

14. The spinal implant of claim 13, wherein the rotation stop is an
annular rim extending proximally from the head.

15. The spinal implant of claim 14, wherein the stabilization member
includes an annular expandable sidewall configured to receive the head
and having a radius greater than a radius of the annular rim, at least a
portion of the annular expandable sidewall configured to engage at least
a portion of the annular rim to limit rotational motion of the head
relative to the stabilization member.

16. The spinal implant of claim 13, wherein the stabilization member
includes a plurality of bone engaging tines extending distally from the
annular expandable sidewall and configured to engage bone.

17. The spinal implant of claim 13, wherein the head includes an
expandable opening formed therein configured for receiving a set screw.

18. The spinal implant of claim 16, wherein the head is configured to
expand and interlock with the stabilization member when a set screw is
threaded into the expandable opening.

19. The spinal implant of claim 13, wherein the stabilization member has
a length and a width orthogonal to the length, the length being greater
than the width.

20. The spinal implant of claim 19, wherein the stabilization member
includes a plurality of expandable arms extending proximally therefrom in
a substantially circular configuration, the expandable arms being
configured to receive the head and a central axis of the expandable arms
being offset from a central axis of the stabilization member.

21. The spinal implant of claim 19, wherein the stabilization member
includes a bend zone formed therein configured to allow one side of the
stabilization member to bend relative to an opposite side of the
stabilization member to conform to a bone surface.

22. The spinal implant of claim 13, wherein the stabilization member
includes a cavity formed therein configured to be filled with a
fusion-promoting bioactive material.

23. A spinal implant, comprising: an elongate member having a distal
shank with a thread extending over at least a portion thereof and a
substantially spherical proximal head coupled to a stabilization member,
the stabilization member being configured to allow rotation of the
elongate member in all directions relative to the stabilization member,
the stabilization member including a plurality of expandable arms
defining an opening for receiving the proximal head, the expandable arms
being movable between a first diameter which is less than a diameter of
the proximal head and a second diameter which is greater than the
diameter of the proximal head.

24. The spinal implant of claim 23, wherein the proximal head includes an
annular rim extending proximally therefrom and configured to engage the
plurality of expandable arms to limit rotation of the elongate member.

25. The spinal implant of claim 23, wherein the stabilization member
includes a plurality of bone engaging tines extending distally therefrom.

26. The spinal implant of claim 23, wherein the proximal head is
expandable.

27. The spinal implant of claim 23, wherein the plurality of expandable
arms are disposed in a substantially circular configuration defining a
central axis.

28. The spinal implant of claim 27, wherein the stabilization member
includes a lateral extension such that the central axis of the expandable
arms are offset from a central axis of the stabilization member.

29. The spinal implant of claim 27, wherein the stabilization member
includes a bend zone disposed between the lateral extension and the
expandable arms, the bend zone configured to allow the lateral extension
to be bent at an angle relative to the expandable arms.

Description:

FIELD

[0001] The present invention relates to methods and devices for spinal
stabilization and fusion, and particularly to stabilization and fusion of
a facet joint.

BACKGROUND

[0002] The vertebrae in a patient's spinal column are linked to one
another by the intevertebral disc and the facet joints. This three joint
complex controls the movement of the vertebrae relative to one another.
Each vertebra has a pair of articulating surfaces located on the left
side, and a pair of articulating surfaces located on the right side, and
each pair includes a superior articular surface and an inferior articular
surface. Together the superior and inferior articular surfaces of
adjacent vertebrae form a facet joint. Facet joints are synovial joints,
which means that each joint is surrounded by a capsule of connective
tissue and produces a fluid to nourish and lubricate the joint. The joint
surfaces are coated with cartilage allowing the joints to move or
articulate relative to one another.

[0003] Diseased, degenerated, impaired, or otherwise painful facet joints
and/or discs can require surgery to restore function to the three joint
complex. In the lumbar spine, for example, one form of treatment to
stabilize the spine and to relieve pain involves fusion of the facet
joint. There are various techniques for stabilizing and treating the
facet joint. However, current instrumentation can limit the available
techniques by requiring specific insertion trajectories and/or by
providing limited options for securement to the various anatomies
surrounding the facet joint.

[0004] Accordingly, there is a need for instrumentation and techniques
that can facilitate insertion and securement of implants in various
orientations and to varied bony anatomies to facilitate the safe and
effective stabilization of facet joints.

SUMMARY

[0005] Spinal implants and methods relating to stabilization and/or fusion
of a facet joint. In general, the implant functions as a sort of
mechanical staple and/or key that prevents sliding motion between the
diarthroidal surfaces of the facet joint. Further, the spinal implant can
include a fusion-promoting bioactive material thereby providing for a
single spinal implant capable of allowing for both fixation and fusion of
a desired facet joint. Various aspects of the implants and methods are
summarized immediately below.

[0006] In one aspect, the spinal implant can include a cannulated elongate
member having a proximal head with a shank extending distally therefrom.
The shank can have a thread extending over at least a portion thereof,
and a portion thereof can remain unthreaded. In some embodiments, the
proximal head can be substantially spherical with an annular rim
extending proximally therefrom. The spinal implant can also include a
stabilization member configured to rotate in all directions relative to
the proximal head of the elongate member. In another embodiment, the
stabilization member can have a proximal portion with an expandable
diameter that is configured to seat the proximal head of the elongate
member. The annular rim can be configured to limit rotation of the
stabilization member to prevent the stabilization member from extending
over a proximal surface of the proximal head.

[0007] The stabilization member can have many configurations and can
include a distal portion having at least one feature configured to engage
a bony portion of a facet joint. For example, the distal portion can
include a plurality of bone piercing tines configured to engage a bony
portion of a facet joint. An outer surface of the plurality of bone
piercing tines can be angled inward toward the shank. The proximal
portion of the stabilization member can include a plurality of arms
configured to expand to engage the proximal head.

[0008] The proximal head can also have many configurations. For example,
the proximal head can include an expandable opening formed in a proximal
portion thereof and concentrically aligned with the annular rim. In some
embodiments, the expandable opening can be configured to receive a set
screw. The proximal head and the annular rim can include at least one
slit formed in a sidewall thereof configured to allow the proximal head
to expand to receive a set screw. The proximal head and the annular rim
can be configured to expand to engage and interlock with the
stabilization member when a set screw is disposed within the expandable
opening. The proximal head can also include a driving feature disposed
distally to the expandable opening and configured to receive a driving
tool to facilitate insertion of the elongate member. Any portion of the
implant can include a fusion-promoting bioactive material.

[0009] In another aspect, a spinal implant is provided and can include a
distal bone engaging shank having a thread extending over at least a
portion thereof. A head can be formed on a proximal end of the shank and
can be coupled to a stabilization member. The head can be configured for
rotational movement in all directions relative to the stabilization
member, and a rotation stop can be formed on a proximal portion of the
head and configured to engage a proximal portion of the stabilization
member to limit rotational motion of the head relative to the
stabilization member. In some embodiments, the rotation stop can be an
annular rim extending proximally from the head. The head can optionally
include an expandable opening formed therein configured for receiving a
set screw. The head can be configured to expand and interlock with the
stabilization member when a set screw is threaded into the expandable
opening.

[0010] The stabilization member can have many configurations and can
include, for example, an annular expandable sidewall configured to
receive the head. The sidewall can have a radius greater than a radius of
the annular rim, and at least a portion of the annular expandable
sidewall can be configured to engage at least a portion of the annular
rim to limit rotational motion of the head relative to the stabilization
member. The stabilization member can also include a plurality of bone
engaging tines extending distally from the annular expandable sidewall
and configured to engage bone. The stabilization member can have a length
and a width orthogonal to the length, the length being greater than the
width. In one embodiment, the stabilization member can include a
plurality of expandable arms extending proximally therefrom in a
substantially circular configuration. The expandable arms can be
configured to receive the head and a central axis of the expandable arms
can be offset from a central axis of the stabilization member. In some
embodiments, the stabilization member can include a bend zone formed
therein configured to allow one side of the stabilization member to bend
relative to an opposite side of the stabilization member to conform to a
bone surface. The stabilization member can also include a cavity formed
therein configured to be filled with a fusion-promoting bioactive
material.

[0011] In a further aspect, a spinal implant is provided and can include
an elongate member having a distal shank with a thread extending over at
least a portion thereof and a substantially spherical proximal head
coupled to a stabilization member. The stabilization member can be
configured to allow rotation of the elongate member in all directions
relative to the stabilization member. In some embodiments, the
stabilization member can include a plurality of expandable arms defining
an opening for receiving the proximal head, and can be movable between a
first diameter which is less than a diameter of the proximal head and a
second diameter which is greater than the diameter of the proximal head.

[0012] In one embodiment, the proximal head can include an annular rim
extending proximally therefrom and configured to engage the plurality of
expandable arms to limit rotation of the elongate member. The
stabilization member can also include a plurality of bone engaging tines
extending distally therefrom. The proximal head can optionally be
expandable, and the plurality of expandable arms can be disposed in a
substantially circular configuration defining a central axis. In another
embodiment, the stabilization member can include a lateral extension such
that the central axis of the expandable arms are offset from a central
axis of the stabilization member. The stabilization member can further
include a bend zone disposed between the lateral extension and the
expandable arms. The bend zone can be configured to allow the lateral
extension to be bent at an angle relative to the expandable arms.

[0013] In another aspect, a spinal implant is provided and can include a
cannulated elongate member having a first bone engaging portion with a
first diameter and a second bone engaging portion with a second diameter.
While the first and second bone engaging portions can have any diameter,
in some embodiments, the first diameter can be greater than the second
diameter. The first bone engaging portion can be configured for insertion
into a facet joint and the second bone engaging portion can be configured
for insertion into a pedicle. In some embodiments, at least one of the
first and second bone engaging portions can have at least one opening
formed in a sidewall thereof and configured to receive an osteoconductive
composition.

[0014] The spinal implant can include a stabilization member configured to
seat the elongate member. The stabilization member can have a first
expandable portion configured to engage a portion of the elongate member
and a second bone engaging portion having a plurality of bone engaging
tines extending therefrom. Each bone engaging tine can be angled toward a
central axis of the elongate member. In one embodiment, at least one of
the first and second bone engaging portions can have a plurality of
openings formed in the sidewall thereof. Each of the plurality of
openings can be a different shape.

[0015] The elongate member can include a proximal head with a shank
extending distally therefrom. The shank can have a thread extending over
at least a portion thereof. The first expandable portion of the
stabilization member can include a plurality of substantially flexible
arms arranged in a circular configuration. Each arm can be separated from
adjacent arms by a slit configured to allow expansion and contraction of
the arms. In some embodiments, the plurality of substantially flexible
arms are configured to receive a proximal head of the elongate member and
to allow rotation in all directions of the proximal head relative
thereto. The stabilization member can optionally include a lateral
extension such that a central axis of the first expandable portion is
offset from a central axis of the stabilization member. The lateral
extension can be configured to bend relative to the first expandable
portion to conform to a bony surface adjacent to a facet joint as the
elongate member is positioned within the facet joint.

[0016] In a further aspect, a spinal implant is provided and can include
an elongate member having a proximal head and a bone engaging shank
extending distally from the proximal head. The proximal head can be
configured for rotational movement in all directions within a
stabilization member. In some embodiments, the shank can have at least
first and second openings formed in a sidewall thereof and can be
configured to receive an osteoconductive composition. The shank can
further have a thread extending over at least a portion thereof, and a
first portion with a first major diameter and a second portion with a
second major diameter, in which the first major diameter can be greater
than the second major diameter.

[0017] In one embodiment, the first and second openings can be disposed
along a longitudinal axis of the elongate member. The first and second
openings can have many different configurations including different sizes
and different shapes. The spinal implant can also include a stabilization
member configured to seat the elongate member. In some embodiments, the
stabilization member can include a stabilizing plate portion having a
plurality of bone engaging tines extending distally therefrom for
piercing bone. Further, the stabilization member can include a
stabilizing plate portion having a plurality of expandable arms extending
proximally therefrom configured to receive the proximal head of the
elongate member.

[0018] While the stabilizing plate portion can have many configurations,
in one embodiment, the stabilizing plate portion can have a length
extending between first and second opposed sides and a width extending
between third and fourth opposed sides, wherein the length is greater
than the width. The stabilizing plate portion can optionally include an
extension member extending distally from one of the first and second
opposed sides. The extension member can have a length greater than a
length of the plurality of bone engaging tines. In another embodiment,
the stabilizing plate portion can include at least one bendable region
disposed thereon such that the stabilizing plate portion is bendable
along a line orthogonal to the length of the stabilizing plate portion.

[0019] In one exemplary embodiment, the stabilization member can include a
translation plate disposed adjacent to the stabilizing plate portion. The
translation plate can have a plurality of expandable arms extending
proximally therefrom configured to receive the proximal head of the
elongate member and to allow rotational movement of the proximal head in
all directions relative to the stabilization member. The translation
plate can be configured to translate laterally with the elongate member
relative to the stabilizing plate portion along the length of the
stabilizing plate portion.

[0020] In other embodiments, the stabilizing plate portion can include a
plurality of expandable arms extending proximally therefrom defining a
first opening disposed adjacent to one of the first side and the second
side and offset from a central axis of the stabilizing plate portion, as
well as a second opening formed on the first or second side opposite to
that of the first opening. The expandable arms can be configured to
receive the proximal head, and the first opening can be configured to
receive the elongate member. The second opening can be configured to
receive the second elongate member therethrough. In some embodiments, the
second elongate member can be a lamina screw configured to engage a
lamina while the elongate member is engaged within a facet joint. The
stabilizing plate portion can also optionally include a first portion and
a second portion, the first and second portions being coupled together by
an adjustable coupling. The adjustable coupling can be configured to
allow translation of the first portion relative to the second portion and
bending of the first portion relative to the second portion.

[0021] In another aspect, a method of implanting a spinal implant is
provided and can include providing an elongate member having a first bone
engaging portion and a second bone engaging portion. At least one of the
first and second bone engaging portions can have at least one opening
formed therein for receiving an osteoconductive composition. The method
can further include packing an osteoconductive composition into the
opening and surgically delivering the elongate member into a vertebra
such that the first bone engaging portion is disposed within a facet
joint and the second bone engaging portion is disposed within a pedicle.
The method can also include engaging a stabilization member coupled to
the elongate member to a bony portion of a vertebra adjacent to the facet
joint in which the elongate member is disposed. Further, the
stabilization member can be bent to engage a bony portion of a vertebra
adjacent to the facet joint in which the elongate member is disposed.

[0022] In some embodiments, the method can further include delivering a
first spinal implant to a first facet joint and a second spinal implant
to a second, corresponding facet joint at the same level of a spine. The
surgically delivering step can be conducted in a minimally invasive
surgical procedure. A lamina screw can also be delivered to a vertebral
lamina through an opening in the stabilization member to provide
additional stabilization for the elongate member disposed within the
facet joint.

[0023] These aspects and others will be described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The invention will be more fully understood from the following
detailed description taken in conjunction with the accompanying drawings,
in which:

[0025]FIG. 1A is a cross-sectional view of an exemplary implant disposed
within a facet joint;

[0059]FIG. 15A is a perspective view of exemplary implants disposed
within a facet joint in a trans-facet orientation;

[0060]FIG. 15B is a perspective view of exemplary implants disposed
within a facet joint in an intra-facet orientation; and

[0061]FIG. 15c illustrates a trajectory of an exemplary implant through
the facet joint and into the pedicle.

DETAILED DESCRIPTION OF THE INVENTION

[0062] Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein. One or
more examples of these embodiments are illustrated in the accompanying
drawings. Those skilled in the art will understand that the devices and
methods specifically described herein and illustrated in the accompanying
drawings are non-limiting exemplary embodiments and that the scope of the
present invention is defined solely by the claims. The features
illustrated or described in connection with one exemplary embodiment may
be combined with the features of other embodiments. Such modifications
and variations are intended to be included within the scope of the
present invention.

[0063] In general, spinal implants and methods for spinal stabilization
and/or fusion are provided. Exemplary implants described herein can be
configured for delivery to a facet joint to stabilize and/or fuse the
facet joint, and can optionally be anchored within the pedicle for added
fixation. As shown in FIGS. 1A and 1B, an exemplary implant 2 can
generally include an elongate member 4, such as a bone screw or fastener,
polyaxially coupled to a stabilization member 6, such as a bone engaging
washer. The elongate member 4 can be disposed within the facet joint as
shown, while the stabilization member 6 can engage an outer portion
(e.g., an edge) of a facet joint to co-join the facet faces. In an
exemplary method of using the implant 2, the elongate member 4 and the
stabilization member 6 can be delivered to and inserted within and/or
around the facet joint in a desired configuration and at a desired angle.
The stabilization member 6 and the elongate member 4 can be rotated
polyaxially (e.g., in all directions) relative to one another to achieve
an optimal angle within and/or around the facet joint before being
secured thereto. For example, the relative angular orientation of the
elongate member 4 and the stabilization member 6 can thus be adjusted as
needed to accommodate different positions within the facet joint, as well
as various shaped anatomical structures, thereby allowing for a better
fit of the implant 2.

[0064] Any of the exemplary implants described herein can also have
features that allow for variable placement of a stabilization member
and/or an elongate member within and/or around the facet joint to
facilitate facet stabilization and/or fusion. For example, exemplary
stabilization members can have laterally extended portions and/or
bendable portions that allow for the placement of additional securement
components, and that generally allow for more flexibility in placement of
the implant in and around the facet joint. In addition, exemplary
implants can have repositioning mechanisms and/or adjustable coulings
associated therewith that allow variability in the anchoring trajectory
of the implant. Various exemplary embodiments of elongate members and
stabilization members for use in these ways will be described herein.

[0065] Referring now to FIGS. 2A and 2B, a more detailed exemplary
embodiment of a spinal implant 10 is provided. The spinal implant 10 can
include an elongate member 14 coupled to a stabilization member 12. The
elongate member 14 can extend from a distal end 16 to a proximal end 18.
A head 20 can be formed on the proximal end 18, and a shank 22 can extend
distally from the head 20. The stabilization member 12 can couple to the
head 20 of the elongate member 14 by circumferentially encircling the
head 20. The elongate member 14 can generally be configured to rotate
polyaxially relative to the stabilization member to allow the
stabilization member 12 to adapt to various anatomical structures during
placement within the facet joint.

[0066] The elongate member 14 can take many different forms, including the
forms of a pin, a dowel, a plug, a beam, a post, a threaded post, a bolt,
an expansion barrel, a pop-rivet, a staple, an anchor, a screw, etc. In
the illustrated embodiment, the elongate member 14 is in the form of a
bone screw configured for placement within a facet joint. The elongate
member 14 can be cannulated such that a lumen 15 extends through the
elongate member 14 along a central longitudinal axis of the elongate
member 14. The lumen 15 can be configured to receive a guide wire, such
as a Kirschner wire, to help facilitate insertion of the implant 10
and/or can be configured for packing with a bioactive osteoconductive
composition, as will be described in more detail below. In other
embodiments, the elongate member 14 can be solid, without a lumen 15
extending therethrough.

[0067] The elongate member 14 can also include one or more features to
facilitate engagement between the shank 22 and bone. For example, a
thread 24 can extend around at least a portion of the shank 22 of the
elongate member 14 to facilitate engagement between the shank 22 and
bone. In some embodiments, at least a portion 25 of the shank 22 can
remain unthreaded. As will be appreciated by those skilled in the art,
any portion of the shank 22 can be threaded or unthreaded. For example,
all of the shank 22 can be threaded or all of the shank 22 can remain
unthreaded, and the thread 22 can be continuous or non-continuous.
Further, the shank 22 can include more than one thread, including two
helical threads and/or two or more threads having different pitches,
different major diameters, etc. The shank 22 can have a major diameter
DM defined by the outer diameter of the threads, and a minor
diameter Dm defined by the diameter of the unthreaded shank. In the
illustrated embodiment, the thread 22 can have a substantially constant
thread crest height, thickness, and pitch along a length of the shank 22.
As will be appreciated by those skilled in the art, thread parameters can
be optimized for a particular embodiment to provide desired engagement
characteristics in the bone.

[0068] The head 20 of the elongate member 14 can also have many
configurations, and can have any size and shape as desired. In the
illustrated embodiment, the head 20 is substantially spherical with a
diameter larger than the major diameter DM of the shank 22. The head
20 can also be substantially cylindrical, rectangular, etc. and can have
a diameter smaller than a diameter DM of the shank. The head 20 can
have an opening 26 formed in a proximal end thereof that can be
configured for receiving a driving tool to facilitate insertion of the
elongate member 14. For example, the opening 26 can have features formed
therein that will complement features on a driving tool to facilitate
rotation of the elongate member 14 into bone. The head 20 can also
include an annular rim 28 extending proximally therefrom. In the
illustrated embodiment, a circumference of the annular rim 28 defines the
opening 26. The annular rim 28 can have any height and width desired, and
can have a circumference and/or diameter as is appropriate for a
particularly sized head 20. For example, the annular rim can have a
diameter in the range of about 3 mm to about 10 mm and a height in the
range of about 0.25 mm to about 5 mm. In some embodiments, the height of
the annular rim 28 can be sufficient to limit rotation of the elongate
member 14 relative to the stabilization member 12 by preventing the
stabilization member 12 from rotating over the proximal end 18 of the
elongate member 14, as will be described in more detail below.

[0069] The stabilization member 12 can generally be configured to
stabilize the elongate member 14 when it is engaged with bone and to
prevent over-insertion of the elongate member 14. As shown in FIGS. 2B
and 3B, the stabilization member 12 can have a substantially circular
and/or partial spherical shape for encircling the substantially spherical
head 20 of the elongate member 14. The stabilization member 12 can
include a stabilizing plate portion portion 30 having an elongate member
receiving portion 34 extending proximally therefrom for receiving the
head 20 of the elongate member 14, and a bone engaging portion 36
extending distally therefrom for engaging bone. The stabilizing plate
portion 30 can be a plate-like member, which may or may not be
continuous, and that extends in a lateral plane orthogonal to a central
axis CA of the stabilization member 12. An opening 32 can extend through
a center of the stabilization member 12 and can be concentrically aligned
with a central axis CA of the stabilization member 12.

[0070] The elongate member receiving portion 34 extending proximally from
the stabilization member 12 can have any configuration suitable for
receiving the head 20 of the elongate member 14. In the illustrated
embodiment, the elongate member receiving portion 34 can have a partial
spherical shape so that it can receive the substantially spherical head
20 of the elongate member 14. More particularly, the elongate member
receiving portion 34 can be composed of one or more flexible and/or
expandable arms 38 that extend proximally from the stabilizing plate
portion 30. In the illustrated embodiment, a plurality of the flexible
and/or expandable arms 38 extend proximally from the stabilizing plate
portion 30 and are each separated by a slit or opening 40 to allow
expansion and contraction thereof. The arms 38 can provide the
stabilization member 12 with a "snap-fit" onto the spherical head 20 and
can allow polyaxial movement of the stabilization member 12 relative to
the head 20. The arms 38 can have any shape and configuration desired,
but in the illustrated embodiment, each arm 38 has a substantially
rounded wedge shape such that an inner surface 56 of the arm 38 is curved
to match the curve of the substantially spherical head 20 of the elongate
member 14. An outer surface 58 of the arm 38 can curve distally outward
in a wedge configuration. A distal portion of each arm 38 can be thinned
to form a bend zone 58 to provide the arms 38 with flexibility such that
the arms 38 flex, expand, and contract, about the bend zone 58.

[0071] As noted above, the stabilization member 12 can also have a bone
engaging portion 36 extending therefrom. The bone engaging portion 36 of
the stabilization member 12 can have any configuration suitable for
engaging, gripping, piercing, and/or penetrating bone. One or more
features can extend distally from the stabilizing plate portion 30 to
facilitate engagement with the bone. In the illustrated embodiment, a
plurality of bone engaging tines 42 extend distally from the stabilizing
plate portion 30 and can be configured for engaging, gripping, piercing,
and/or penetrating bone. The tines 42 can be of different sizes and
shapes, and can be adapted to perform different functions as needed. In
this embodiment, the tines 42 can decrease in width as they extend
distally until they form a bone piercing and/or penetrating tip 44.

[0072] The tines 42 extending from the stabilizing plate portion 30 can be
arranged in many configurations. In some embodiments, a proximal portion
46 of the tine 42 can extend distally and substantially orthogonally from
the stabilizing plate portion 30 such that the tines 42 have an outer
diameter substantially the same as an outer diameter of the stabilizing
plate portion 30. An outer surface 48 of a distal portion 54 of the tine
42 can bend inward toward the shank 22 such that the outer surface 48 of
the distal portion 54 is angled relative to the outer surface 50 of the
proximal portion 46, for example at an angle in a range of about 5
degrees to about 60 degrees, and more preferably in a range of about 10
degrees to about 45 degrees. An inner surface 52 of the tine 42 can
remain at a substantially constant angle (i.e., substantially orthogonal
to the stabilizing plate portion 30) or it can curve inward slightly
toward the shank 22 with a radius of curvature in the range of about 5 mm
to about 20 mm, for example about 13 mm, as it extends distally from the
stabilizing plate portion 30 across the proximal portion 54 and the
distal portion 46.

[0073] The structure of the tines 42 provide easier bone penetration and a
more secure engagement between the bone and the stabilization member. In
particular, as the bone engaging tines 42 are driven into bone, the
angled outer surface 50 of the tines 42 will cause the stabilization
member 12 to close down and inward to provide a more secure purchase
within bone. In use, when the elongate member 14 is disposed within a
facet joint, a first tine 42 and/or first set of tines 42 can pierce a
top vertebra (or top facet face) while a second tine 42 and/or second set
of tines 42 can pierce an adjacent, bottom vertebra (or opposing facet
face). As such, the stabilization member 12 can effectively act in a
staple-like manner securing the implant 10 within the facet joint.

[0074] As noted above, the implant 10 can include features to limit
rotation of the elongate member 14 relative to the stabilization member
12. For example, as also noted above, the head 20 of the elongate member
14 can include an annular rim 28 extending proximally therefrom that can
be configured to limit rotation of the elongate member 14 relative to the
stabilization member 12 by preventing the stabilization member 12 from
rotating over the proximal end 18 of the elongate member 14. When the
stabilization member 12 is coupled to the head 20 of the elongate member
14, it can rotate polyaxially (i.e., in all directions) relative to the
elongate member 14 due to the complementary spherical shape between the
head 20 of the elongate member 14 and the elongate member receiving
portion 34 of the stabilization member 12. The annular rim 28, however,
can limit the rotation of the stabilization member 12 by blocking the
arms 38 from rotating further over the top of the head 20 of the elongate
member 14. More particularly, as the stabilization member 12 rotates
relative to the head 20, the arms 38 can engage the annular rim 28, which
can prevent the stabilization member 12 from rotating further in that
direction. The stabilization member 12 can rotate in all directions
relative to the elongate member 14 such that the central axis CA of the
stabilization member 12 is at an angle a relative to a central
longitudinal axis LA of the elongate member 14 in the range of about 0
degrees to about 30 degrees. In other words, when the arms 38 of the
stabilization member 12 are engaged with the annular rim 28, the central
axis CA of the stabilization member 12 can be at an angle of about 30
degrees relative to the longitudinal axis LA of the elongate member 14.

[0075] Other exemplary stabilization members are illustrated in FIGS. 3A
and 3C. As shown, stabilization members 12', 12'' are provided and can
have a plurality of expandable arms 38', 38'' extending proximally from a
stabilizing plate portion 30', 30'' and a plurality of bone engaging
tines 42', 42'' extending distally from the stabilizing plate portion
30', 30''. In the embodiment of FIG. 3A, the stabilizing plate portion
30' has an outer diameter substantially the same as an outer diameter of
the expandable arms 38'. The outer diameter can be in the range of about
8 mm to about 20 mm, and more preferably in the range of about 10 mm to
about 15 mm, for example, about 13 mm. As shown in FIG. 3B, the
stabilizing plate portion 30 can have an outer diameter larger than an
outer diameter of the expandable arms 38. The outer diameter of the
stabilizing plate portion 30 can be in the range of about 10 mm to about
25 mm, and more preferably in the range of about 13 mm to about 20 mm,
for example about 16 mm. The stabilizing plate portion shown in FIG. 3c
can have an outer diameter substantially larger than an outer diameter of
the expandable arms 38''. The outer diameter of the stabilizing plate
portion 30'' can be in the range of about 13 mm to about 30 mm, and more
preferably in the range of about 15 mm to about 25 mm, for example about
19 mm. As will be appreciated by those having ordinary skill in the art,
the stabilizing plate portions 30, 30', 30'' and the expandable arms 38,
38', 38'' can have any diameter as desired relative to one another and
relative to an elongate member utilized therewith. The various exemplary
stabilization members 12, 12', 12'' can also have any height as desired.
For example, a particular stabilization member 12, 12', 12'' can have a
height in the range of about 1 mm to about 15 mm, and more preferably
between about 5 mm to about 10 mm, for example, about 6 mm, 7 mm, 8 mm, 9
mm, etc. As will be appreciated by those having ordinary skill in the
art, the stabilization members 12, 12', 12'' can be used with any of the
various elongate members described herein.

[0076] Another embodiment of an elongate member 60 is illustrated in FIGS.
4A and 4B. Similar to the elongate member 14 above, the elongate member
60 can have a shank 62 extending distally from a substantially spherical
head 64. The elongate member 60 can be cannulated with a lumen 66
extending longitudinally therethrough, and the shank 62 can include a
thread 68 extending over at least a portion thereof Further, the head 64
can include an annular rim 70 extending proximally therefrom for limiting
rotation of a stabilization member (not shown). A proximal portion 72 of
the head 64 can optionally include one or more slots 74 formed therein to
allow the head 64 to be expandable. In the illustrated embodiment, the
head 64 includes four slots 74 formed through a sidewall of the head 64
and through the annular rim 70. The four slots 74 define four arms 76 in
the proximal portion 72 of the head 64 that can expand and contract
around an opening 78 formed in the head 64.

[0077] While the opening 78 in the head 64 can have many configurations,
in the illustrated embodiment, a distal portion of the opening 78 can be
configured to receive a delivery tool to facilitate insertion of the
elongate member 60 into bone. A proximal portion of the opening 78 can
have a thread 80 extending therearound such that the opening 78 is
configured to receive a set screw 82 therein. The set screw 82 can be a
threaded member that increases in diameter in a distal to proximal
direction such that as the set screw 82 is threaded into the opening 78,
it expands the opening 78 due to its increasing width. When the elongate
member 60 is coupled to any of the stabilization members described
herein, threading the set screw 82 into the opening 78 in the head 64 can
cause the head 64 to expand and engage the stabilization member more
securely. The set screw 82 can sit flush with a top surface 84 of the
annular rim 70 or it can sit a distance below the top surface 84 of the
annular rim 70. The set screw 82 can be cannulated with a lumen 86 that
can align with the lumen 66 in the elongate member 60. The set screw 82
can also have an opening 88 formed in a proximal surface thereof for
receiving a tool to facilitate insertion of the set screw 82 into the
opening 78 in the head 64.

[0078] Any of the stabilization members and elongate members described
herein can include a bioactive fusion-promoting material capable of
actively participating in spinal fusion. The fusion-promoting material
can be a surface morphology change, such as a roughened surface, to allow
for bony ongrowth, or materials, such as titanium beads or meshes, can be
added to allow bony in-growth. In some embodiments, the stabilization
member and/or the elongate member can be formed from a bioactive
material, thereby allowing the implant to participate in spinal fusion.
In other embodiments, the stabilization member or the elongate member can
include a portion (or a coating) formed from a bio-active fusion
promoting material. In addition, in any of the stabilization member
embodiments described herein, a cavity or opening formed within the
stabilization member can be filled and/or packed with a bio-active fusion
promoting material. The stabilization member shown in FIG. 3B can include
a cavity 90 formed therein in which a bio-active fusion promoting
material can be packed. In other embodiments, an opening or cavity can be
formed within an elongate member for the same purpose. For example, FIGS.
5A-6C and 7 illustrate various embodiments of fusion-promoting elongate
members, as will be described below.

[0079] The fusion-promoting bioactive material can include any material
capable of actively participating in spinal fusion. In an exemplary
embodiment, the bioactive material can be allograft bone material (such
as Allowashed® available from LifeNet, Inc.; Virginia Beach, Va.). In
another example, the material can be a bioresorbable plastic (poly-lactic
acid, polyglycolic acid, their derivatives and/or blends), poly-anhydride
(PolymerDrug® by PolyMerix, Piscataway, N.J.), polymerized sugars or
starches (Eureka® by Surmodics of Eden Prairie, Minn.), bioceramic
(HIP Vitox® alumina or Zyranox® zirconia by Morgan Advanced
Ceramics of Fairfield, N.J.; crystalline hydroxyapatite, tricalcium
phosphates or combinations of these materials by Berkeley Advanced
Biomaterials of San Leandro, Calif.), bioceramic-loaded bioabsorbable
material, or dense protein (Novasilk® by Protein Polymer Technologies
of San Diego, Calif.). Exemplary embodiments of such bioabsorbable
materials include Biocryl® (an 85% PLA/PGA, 15% tricalcium phosphate
material available from Depuy Mitek, a Johnson & Johnson Company;
Raynham, Mass.) or TriABSorb® (a 5% hydroxyapatite, 95% PLA material
available from Depuy Mitek, a Johnson & Johnson Company; Raynham, Mass.).
Preformed plugs produced from TCP or HA. As another example, the material
can be an osseointegrating porous polymer such as PEEK/Optima®
(available from Invibio, Inc.; Greenville, S.C.). The bioactive fusion
promoting material can be autologus bone graft intra-operatively
harvested from the patient. Those skilled in the art will appreciate that
any combination of these materials are within the spirit and scope of the
present invention.

[0080] In one embodiment shown in FIG. 5, an elongate member 100 is
provided having a shank 102 extending distally from a head 104. The
elongate member 100 can be cannulated with a lumen 103 and can be
configured for being inserted into bone. The head 104 can have any shape
and configuration, but in the illustrated embodiment, the head 104 has a
substantially spherical body with a flattened proximal top surface 106.
An opening 108 can be formed in the head 104 to receive a driving tool to
facilitate insertion of the elongate member 100 into bone. The shank 102
can have at least one thread 110 extending therearound, and at least a
portion 112 of the shank 102 can remain unthreaded. A major diameter of
the head 104 can be greater than a major diameter of the shank 102.

[0081] In some embodiments, the shank 102 can optionally include features
to promote fusion. For example, the shank 102 can include a plurality of
openings 114 formed through a sidewall thereof. While the openings 114
can be any size and shape, in the illustrated embodiment there are four
circular openings 114 that extend laterally through the shank 102 in a
direction orthogonal to a central longitudinal axis of the elongate
member 100. The openings 114 can have a diameter less than a distance
between two windings of the thread 110 so that each opening 114 can be
positioned between two windings. The openings 114 can be filled and/or
packed with a bio-active fusion promoting material that can encourage
bone growth through the openings, thereby promoting fusion. The openings
114 can be packed with the bio-active fusion promoting material through
the lumen 103 and/or can be packed directly through the openings 114. In
some embodiments, the openings 114 can be formed within a proximal
portion of the shank 102 that is disposed within the facet joint, as
opposed to a distal portion of the shank 102 disposed within a pedicle.
In this way, fusion between the facet faces is promoted through the use
of the openings 114 filled with the bio-active composition.

[0082] Another exemplary elongate member 120 is illustrated in FIGS. 6A
and 6B. As shown, the elongate member 120 can include a shank 122
extending distally from a head 124. The elongate member 120 can be
cannulated with a lumen 126 extending therethrough and can be configured
to be inserted into bone. The head 124 can have any shape and
configuration, but in the illustrated embodiment, the head 124 has a
substantially spherical body with a flattened proximal top 128. An
opening 130 can be formed in the head 124 to receive a driving tool to
facilitate insertion of the elongate member 120 into bone. The shank 122
can have at least one thread 132 extending therearound. In the
illustrated embodiment, the shank 122 can have two portions with
different diameters. A proximal portion 134 of the shank 122 can have a
first major diameter D1, and a distal portion 136 of the shank 122
can have a second major diameter D2. In this case, the first major
diameter D1 is greater than the second major diameter D2 such
that the larger first diameter D1 can be positioned between and/or
within the facet joint faces, enabling the elongate member 120 to be
stronger at this superficial location. In addition, the larger diameter
D1 can better enable joint stabilization by acting as a "key" to
prevent facet face sliding motion. Furthermore, in some embodiments, the
proximal portion 134 with the larger diameter D1 can have material
removed from sidewalls thereof to enable a bone graft cage configuration
that will encourage bone growth through the elongate member 120 that
spans the facet faces and provides further mechanical stabilization of
the facet joint. A major diameter of the head 124 can be greater than the
first and second major diameters D1, D2 of the shank, although
as will be appreciated by those having ordinary skill in the art, the
major diameter of the head 124 can also be substantially the same as or
smaller than the first major diameter D1 or the second major
diameter D2.

[0083] The shank illustrated in FIGS. 6A and 6B can also have features to
promote fusion. As shown, the shank 122 can include various sized and
shaped openings formed in a sidewall thereof. The shank 122 can include,
for example, three openings spaced longitudinally along a length of the
shank 122 that extend laterally through the body of the shank 122. A
first opening 138 can be an oblong shaped opening that has a width less
than a minor diameter of the shank 122 and a height that spans at least
two windings of the thread 132. A second opening 140 can also be an
oblong opening positioned distal to the first opening 138, but with a
width greater than its height such that it can be positioned between two
windings of the thread 132. A third opening 142 can be a circular opening
positioned distal to the first and second openings 138, 140 and having a
diameter less than the space between two windings of the thread 132. The
openings 138, 140, 142 can be filled and/or packed with a bio-active
fusion promoting material that can encourage bone growth through the
openings 138, 140, 142, thereby promoting fusion.

[0084] As will be appreciated by those skilled in the art, any of the
elongate members described herein can have any number of openings formed
therein, in any configuration. For example, in addition to two opposing
openings within a sidewall of a shank (i.e., one opening laterally
extending through the shank), there can be any number of openings formed
around a circumference of the shank, such as in the elongate member
illustrated in FIG. 12A. A plurality of openings can be formed around the
circumference of a shank, positioned between windings of the thread, such
that there are, for example, 3, 4, 5, 6, 7, 8, 9, 10, or more openings
formed around a circumference of the shank. These openings can have any
desired shape and size. Further, any number of openings can be positioned
longitudinally along a length of the shank of the elongate member.

[0085] Another exemplary elongate member 150 is illustrated in FIG. 7, and
is similar to that shown in FIGS. 6A and 6B with a shank 158 extending
distally from a head 162. Three laterally extending openings 152, 154,
156 can be formed along a length of the shank 158 in a proximal portion
164 thereof for receiving a bio-active fusion promoting material. In this
embodiment, however, a distal portion 160 of the shank is substantially
longer than the proximal portion 164. When inserted into a facet joint,
the distal portion 160 can extend into the pedicle while the proximal
portion 164 is engaged with the facet joint. Anchoring within the pedicle
in this way provides the elongate member 150 with greater stability
within the facet joint.

[0086] The elongate members illustrated in FIGS. 1A-7, and any other
elongate member embodiments described herein, can have any particular
dimension as needed for a particular procedure or anatomy. For example, a
particular elongate member can have a length from a proximal end to a
distal end in the range of about 20 mm to about 80 mm. Generally, the
elongate members shown in FIGS. 1A-6B can have a length in the range of
about 25 mm to about 45 mm, and more preferably in the range of about 30
mm to about 40 mm, for example about 30 mm or about 35 mm. Generally, the
elongate member shown in FIG. 7 can have a length in the range of about
50 mm to about 70 mm, and more preferably in the range of about 55 mm to
about 65 mm, for example 60 mm. A greater diameter of the shanks,
including the proximal and the distal portions of a shank that changes
diameter, can range from about 2 mm to about 15 mm, more preferably from
about 4 mm to about 10 mm, for example, about 5 mm, 6 mm, 7 mm, 8 mm, 9
mm, etc.

[0087] Various stabilization members for use with the various elongate
members are also provided and can be configured in various alternative
shapes and sizes as compared to those substantially circular embodiments
discussed above. The stabilization members can be configured to include
different types of bone engaging features, including bone engaging tines,
serrated/cutting edges, and extension portions, as well as different
shaped and sized bone engaging members disposed on one stabilization
member. In addition, a particular stabilization member can be configured
to include at least one lateral extension that can be in the form of a
"plate-like" configuration, resulting in a substantially oblong,
rectangular, and/or oval shaped stabilization member. In other
embodiments, laterally extended stabilization members can be curvilinear,
both laterally and longitudinally. Such embodiments can be utilized in
either intra-facet and/or trans-facet stabilization of the facet joint.
As will be discussed, a laterally extended configuration allows for
broader engagement across the facet joint so that the stabilization
member makes contact with bony anatomy adjacent to the facet joint, such
as the lamina, lateral facet, or pedicle. This allows the stabilization
member to span the facet to secure, stabilize, and fuse the facet faces.
In some embodiments, a laterally extended stabilization member can be
bendable to provide closer and more complementary engagement across a
facet joint.

[0088] FIGS. 8A-8B illustrate an embodiment of a stabilization member 180
having an extended lateral profile. The stabilization member 180 can have
an elongate member receiving portion 182 with an opening 184 formed
therethrough for receiving a head of an elongate member (not shown). The
stabilization member 180 can also have an extension portion 184 with an
opening 186 formed therethrough. The two portions 184, 186 can be
separated by a bend zone region 188 formed in a stabilizing plate portion
190 of the stabilization member 180. The bend zone region 188 can be a
thinned portion of the stabilizing plate portion 190 that allows the
stabilizing plate portion 190 to be flexible in that region such that the
stabilization member 180 can be bent around a facet joint or other boney
surface to provide better conformation thereto.

[0089] The structure of the stabilization member 180 can be substantially
the same as described above relative to the substantially circular
stabilization members. A plurality of expandable arms 192 can extend
proximally from the stabilizing plate portion 190 in a substantially
circular configuration defining the opening 184 through the elongate
member receiving portion 182. As shown, a central axis of the opening 184
can be offset from a central axis of the stabilization member 180. The
expandable arms 192 can be configured to receive a substantially
spherical head of an elongate member. A plurality of bone engaging tines
194 can extend distally from the oblong shaped stabilizing plate portion
190 around its outer perimeter such that the bone engaging tines 194 are
also in an oblong or oval shape. In this way, when the stabilization
member 180 is bent along its bend zone region 188, the tines 194 will
engage bone around the entire perimeter of the stabilizing plate portion
190.

[0090] FIGS. 9A and 9B illustrate an exemplary stabilization member 180'
substantially identical to that shown in FIGS. 8A and 8B, except with a
longer extension portion 184'. The stabilization members 180, 180' shown
in FIGS. 8A-9B can have any length as needed for a particular procedure
or for a use in a particular anatomy. For example, the stabilization
members 180, 180' can have a length in the range of about 10 mm to about
35 mm, more preferably in the range of about 15 mm to about 30 mm, for
example, about 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25
mm, 26 mm, etc.

[0091] In another embodiment illustrated in FIGS. 10A and 10B, a
stabilization member 200 is provided. The stabilization member 200 can be
extended laterally such that a stabilizing plate portion 202 of the
stabilization member 200 is substantially oblong and/or oval. Similar to
the embodiments described above, the stabilization member 200 can have an
elongate member receiving portion 204 with an opening 206 formed
therethrough and a plurality of expandable arms 208 extending proximally
therefrom in a substantially circular configuration for receiving a
substantially spherical head of an elongate member. As shown, a central
axis of the opening 206 can be offset from a central axis of the
stabilization member 200. The stabilization member 200 can also have an
extension portion 210.

[0092] The stabilizing plate portion 202 can have a plurality of bone
engaging tines 212 extending distally therefrom around a perimeter
thereof. In this embodiment, the bone engaging tines 212 can have an
asymmetric configuration in which one or more of the tines have a length
and/or angular configuration different than a length and/or angular
configuration of at least one other of the tines 212. This can provide
for better purchase within bone and can allow variable placement, for
example, into the lamina or adjacent to a mammillary process. As shown,
the stabilizing plate portion 202 can have an extension portion 213
extending distally from one lateral side thereof configured, for example,
to extend into a pedicular valley. The extension portion 213 can have,
for example, one or more bone engaging members extending therefrom that
are disposed distally and angularly. As shown, two bone engaging tines
212a are angled relative to the other tines 212, and two bone engaging
tines 212b are formed at a distal end of the extension portion 213 and
are thus substantially greater in length than the other tines 212. The
extension portion 213 can provide the stabilization member 200 with a
more aggressive engagement into the bone and thus a more secure purchase
therein.

[0093] The bone engaging tines 212 can be arranged in many different ways,
and in the illustrated embodiment, the tines 212 can each terminate in
such a way as to form an overall curved configuration relative to the
stabilizing plate portion 202, as shown in FIG. 10A. The shorter tines
212 can have any desired shape and configuration, but in the illustrated
embodiment, they have a configuration the same as that described above
with an outer surface 214 angled toward a central axis of the
stabilization member 200 and a bone piercing and/or penetrating tip 216
formed at the distal end. The angled tines 212a can have a non-angled
outer surface 214a with angled bone piercing and/or penetrating tips
216a. Further, the longer tines 212b can have an angled inner surface 218
with a non-angled outer surface 214b and bone piercing and/or penetrating
tips 216b at their distal end. The extension portion 213 can have a
length from the stabilizing plate portion 202 in the range of about 10 mm
to about 20 mm, more preferably in the range of about 13 mm to about 18
mm, for example about 15 mm. A width of the stabilization member can be
the same as described above for the embodiment shown in FIGS. 8A-9B.

[0094] A further embodiment of a stabilization member 230 is illustrated
in FIGS. 11A-11D. In this embodiment, the stabilization member 230 can
have a repositioning mechanism and/or adjustable coupling configured to
allow translation of an elongate member 232 in at least one direction
relative thereto. The stabilization member 230 can be extended laterally
such that its length is longer than its width, and it can accommodate a
movable translation plate 234, shown most clearly in FIG. 11D, to
facilitate translation of the elongate member 232. A stabilizing plate
portion 236 of the stabilization member 230 can have a substantially
rectangular opening 238 formed therein to receive the translation plate
234 and can define rails 240 on which the translation plate 234 can
slide. The translation plate 234 can therefore have a width substantially
the same as the width of the stabilizing plate portion 236, but a length
shorter than the length of the stabilizing plate portion 236 so that it
can translate lengthwise. A plurality of expandable arms 242 can extend
proximally from the translation plate 234 and can define an opening 244
for receiving a head 246 of the elongate member 232. A diameter of the
opening 244 can be substantially the same as the width of the translation
plate 234 and the stabilizing plate portion 236, as shown in FIG. 11D.

[0095] Four sidewalls can define an outer perimeter of the stabilizing
plate portion 236 and can terminate distally in a plurality of bone
engaging tines. Two opposing sidewalls 248, 250 can be symmetric and can
have a number of different length tines 252 arranged in a curved
configuration as shown in FIGS. 11A and 11C. The opposed symmetric
sidewalls 248, 250 can extend proximally a distance above the stabilizing
plate portion 236 in a curved configuration to define sidewalls for the
rails. The other two opposing sidewalls 252, 254 can be asymmetric and
can have asymmetric bone engaging tines formed at a distal end thereof.
One of the asymmetric sidewalls 252 can extend distally in a curved
configuration such that the sidewall 252 forms an arc outward from the
stabilizing plate portion 236 and then inward toward a central axis of
the stabilization member 234 terminating in two distal bone engaging
tines 256 and two side bone engaging tines 258. The bone engaging tines
256 formed at a distal end of the sidewall 252 can have a length
substantially greater than the lengths of the other bone engaging tines
252, 258. The other asymmetric sidewall 254 can extend distally at an
angle relative to the stabilizing plate portion 236 such that the
sidewall 254 is angled away from the central axis of the stabilization
member 230, rather than being orthogonal to the central axis, as with the
symmetric sidewalls 248, 250, or angled toward the central axis, as with
the other asymmetric sidewall 252.

[0096] In use, the translation plate 234 coupled to the elongate member
232 can translate relative to the stabilizing plate portion 236 in a
direction parallel with the opposing symmetric sidewalls 248, 250 or
orthogonal to the opposing asymmetric sidewalls 252, 254. For example, in
some embodiments, the translation plate 234 can translate by a distance
in the range of about 5% to about 40% of a length of the stabilization
member 230. In an embodiment in which the length of the stabilization
member 230 is about 16 mm, the translation plate 234 can translate about
4 mm (about 25%) in each direction. As will be appreciate by those
skilled in the art, the stabilization member 230 can have any length as
needed for a particular procedure and/or to fit a particular anatomy.

[0097] Another exemplary embodiment of an implant 260 is illustrated in
FIGS. 12A-12E. In this embodiment, the implant 260 can include a
laterally extended stabilization member 262 configured to receive both an
elongate member 264 and a fixation screw 266. A stabilizing plate portion
268 of the stabilization member 262 can be substantially oblong and/or
oval. A first side 270 of the stabilizing plate portion 268 can have an
opening 272 formed therethrough defined by a plurality of expandable arms
274 extending proximally from the stabilizing plate portion 268 and
configured to receive a substantially spherical head 276 of the elongate
member 264 therein. The opening 272 can be configured to allow polyaxial
rotation of the elongate member 264 relative to the stabilization member
262. A second side 278 of the stabilizing plate portion 268 can have an
opening 280 formed therethrough configured to receive the fixation screw
266. A diameter of the opening 280 can be smaller than a diameter of the
opening 272. As with previous embodiments, a plurality of bone engaging
tines 282 can extend distally from the stabilizing plate portion 268
around a perimeter of the stabilizing plate portion 268.

[0098] One or more bend zone regions 284 can be disposed between the first
and second sides 270, 278. The bend zone regions 284 can be thinned
portions of the stabilizing plate portion 268 that are flexible and thus
able to be bent such that each of the first and second sides 270, 278 can
be disposed at a different angle in bone relative to one another. This
can allow the implant 260 to be more versatile and to more easily engage
with a wider variety of bone surfaces and anatomies.

[0099] Any of the elongate members described herein can be disposed within
the opening 280 in the first side 270 of the stabilizing plate portion
268. Further, while any type of elongate member can be used within the
opening 272 in the second side 278 of the stabilizing plate portion 268,
in the illustrated embodiment, the lamina fixation screw 266 is utilized.
The fixation screw 266 can have a flattened head 286 with a shank 288
extending distally therefrom. The shank 288 can have a thread 290
disposed therearound and can have a diameter that decreases in a proximal
to distal direction. The use of the fixation screw 266 with the elongate
member 264 can provide a more secure and stable attachment to bone. For
example, while the elongate member 264 is disposed within the facet
joint, the fixation screw 266 can be disposed within the lamina to
provide a more secure attachment for the elongate member 264. Further,
the stabilizing plate portion 268 can be bent along its one or more bend
zone regions 284 so that the stabilization member 262 can more closely
form to the anatomy of the bone.

[0100] Another embodiment of an implant similar to that in FIGS. 12A-12E,
and having a repositioning mechanism and/or adjustable coupling
associated therewith, is illustrated in FIGS. 13A and 13B. A
stabilization member 300 is provided having first and second sides 302,
304, each side 302, 304 configured to receive one of a fixation screw 306
and an elongate member 308. In this case, however, a bend zone region 310
is in the form of a "T key" with one side 312 being in the shape of a T
and the other side 314 having a complementary shape for receiving the T.
The bend zone region 310 can be bendable, as well as laterally
adjustable, and can thus be expanded laterally and/or bent to fit a
particular anatomy. As will be appreciated by those skilled in the art,
any shaped interlocking configuration can be used in the bend zone region
310 to facilitate lateral adjustment of the region.

[0101] FIGS. 14A-14D illustrate another embodiment of an implant having a
repositioning mechanism and/or adjustable coupling. As shown, a
stabilization member 320 is provided having a slotted opening 322 formed
therethrough. A plurality of bone engaging members 324 can extend
distally therefrom for engaging a bony surface, and a plurality of teeth
326 can be formed in a proximal surface thereof for engaging
corresponding teeth in a head 330 of an elongate member 332, shown in
FIG. 14c. The elongate member 332 can have a substantially flattened head
330 with a distal surface having a plurality of teeth 328 for engaging
the teeth 326 formed in the proximal surface of the stabilization member
320. A shank 334 can extend distally from the head 330. When the elongate
member 332 is disposed within the slotted opening 322 in the
stabilization member 320, it can be moved laterally to a desired position
along the member 320. Engagement between the teeth 326, 328 prevent
further movement once positioned. In some embodiments, the stabilization
member 320 can be bendable along its slotted opening 322 to facilitate
attachment to a variety of bony surfaces and anatomies.

[0102] The above implant embodiments can be formed of any suitable
material known in the art. A particular stabilization member and elongate
member can be formed of the same material or of different materials. In
addition, different portions of a particular stabilization member or
elongate member can be formed of different materials. In some
embodiments, the implant or a portion thereof can be formed from titanium
or a titanium alloy, polyether ether ketone (PEEK), ceramic, 316
stainless steel, CoCr, trabecular metals, zirconia, crystalline
hydroxyapatite, TCP, poly-lactic acid & poly-glycolic acid and blends
thereof, etc. In other embodiments, the implant or a portion thereof, can
be formed of Nitinol. The temperature characteristics of Nitinol can
allow the stabilization member and/or the elongate member to expand or
contract when disposed in bone to facilitate better placement and
securement with a particular location, as well as to reduce loosening of
the implant once implanted.

[0103] The various implant embodiments disclosed herein can generally be
utilized to provide fixation and/or fusion to a facet joint. The various
elongate members described herein can be delivered into a facet joint,
and in some embodiments, can be anchored into the pedicle for added
fixation. The various stabilization member embodiments described herein
can be used to mechanically co join the facet faces. An overview of facet
joint anatomy and prior art methods of providing spinal fixation to a
facet joint can be found in U.S. Patent Application No. 2008/0255622,
filed on Apr. 13, 2007 and entitled "Facet Fixation and Fusion Screw and
Washer Assembly and Method of Use," which is incorporated by reference in
its entirety.

[0104] In use, an exemplary elongate member coupled to an exemplary
stabilization member can be provided for insertion into a facet joint.
The elongate member and/or the stabilization member can optionally be
packed with, formed from, or and/or coated with a bio-active fusion
promoting composition. The insertion procedure can preferably be
performed minimally invasively, although it can be performed using any
surgical procedure now in use or yet to be. The elongate member and
stabilization member can be delivered into and secured within and around
the facet joint and pedicle in a number of ways. For example, in some
embodiments, the implant can be inserted using various trajectories that
start in intra-facet (between the facet faces) or trans-facet (through
the facet faces) and subsequently pass close to the centroid of the
pedicular bone that connects the vertebral body to the lamina. More
particularly, the elongate member can be placed in between the facet
faces in an intra-facet pedicular trajectory, as shown in FIG. 15B, or
can be placed in a trans-facet trajectory, as shown in FIG. 15A. In other
embodiments, the implant can be inserted using various trajectories that
do not start within or pass through the facet joint but pass close to the
centroid of the pedicular bone that connects the vertebral body to the
lamina, including entry into the lateral aspect of that facet or entry
directly into the pedicle. For example, the implant can be placed into
the pedicle valley in a traditional pedicular trajectory, as shown in
FIG. 15c, and/or it can placed into the mammillary process.

[0105] While there are a number of different ways in which rrthe implant
can be delivered to the facet joint, in one embodiment, the stabilization
member can be delivered to the facet joint first, before delivery of the
elongate member. An opening can be formed within the patient and a
guidewire can be inserted using fluoroscopy and other conventional
techniques. Serial dilation can be performed to provide access through
tissue to the facet joint. An opening for the elongate member can be
drilled into, within, or near the facet joint at the desired insertion
trajectory. The stabilization member can be delivered to the facet joint
area for sizing, followed by awling of any securement features. The
stabilization member can then be secured to the desired anatomy by
piercing the bone with the bone engaging members. If the stabilization
member has bending features, lateral extensions, or other additional
securement features, they can be manipulated and/or utilized to provide
additional engagement and stabilization. For example, a portion of the
bone engaging members of the stabilization member can engage an outer
portion of the facet of a first vertebra and another portion of the bone
engaging members can engage an outer portion of the facet of a second,
adjacent vertebra. The stabilization member can be bent around these
portions and/or laterally adjusted to an appropriate length for
engagement with these portions. Once the stabilization member is secured,
the elongate member can be inserted through an opening within the
stabilization member and into the predrilled opening within, through, or
around the facet joint. In some embodiments, a set screw can be placed
into an opening within a head of the elongate member to expand the head
into tighter interlocking engagement with the stabilization member. In
other embodiments, the stabilization member and the elongate member can
be delivered to and implanted within or around the facet joint as a
coupled implant using the above-described techniques.

[0106] The implants described herein can be used, for example, in facet
volume restoration procedures and/or partial correction of coronal plane
deformity (scoliosis) at one or more vertebral levels. This enables the
implant to be used as a fusion device and permits deformity correction at
one or more levels. Further, the implant can be used for thoracic spine
facet joint fusion and deformity correction, and can also assist in
deformity correction when used with mono-portal transforaminal lumbar
interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) to
correct disc height lost, coronal deformity, and foraminal volume loss.
The implants can further be used in other procedures such as posterior
stabilization for an anterior lumbar interbody fusion (ALIF 360),
reduction of low-grade spondylolisthesis, or terminal fusion of diseased
and painful facet joints.

[0107] In some embodiments, a system or kit is provided and can include
one or more of the exemplary implants, stabilization members, and/or
elongate members described herein. In addition, the system or kit can
include one or more tools that permit delivery and insertion, as well as
some longitudinal distraction of the facet joint. Any of the
stabilization member and elongate member embodiments disclosed herein can
be included in such a system or kit and can be fully interchangeable with
one another.

[0108] One skilled in the art will appreciate further features and
advantages of the invention based on the above-described embodiments.
Accordingly, the invention is not to be limited by what has been
particularly shown and described, except as indicated by the appended
claims. All publications and references cited herein are expressly
incorporated herein by reference in their entirety.